Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 1:04 PM
Study NCT ID:
NCT05491759
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2022-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine Optimal Absorption of Single Dose Omega-3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma EPA+DHA as measured by AUC0-24', 'timeFrame': '0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion', 'description': 'Change in plasma EPA+DHA from baseline as measured by AUC0-24'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '24 hours post ingestion', 'description': 'Peak plasma concentration'}, {'measure': 'Tmax', 'timeFrame': '24 hours post ingestion', 'description': 'Time to peak plasma concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Optimal Gastrointestinal Absorption of Omega-3']}, 'descriptionModule': {'briefSummary': 'This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and females over 19 years and otherwise healthy\n* Healthy BMI \\>18.0 and \\<30.0\n* Able to provide informed consent\n* Agree to arrive fasted on the day of the trial\n* Agree to participate in all arms of the study\n\nExclusion Criteria:\n\n* Unstable or serious illness \\[e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy\\]\\*\n* Any treatment that included radiation or chemotherapy within the previous 2 years\n* Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.\n* Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #\n* Active smokers, nicotine, alcohol, drug abuse\n* Chronic past and/or current alcohol use (\\>14 alcoholic drinks week)\n* Allergic to any of the ingredients (i.e., fish oil)\n* Pregnant or lactating women\n* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion\n\n * An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.\n\n * Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.'}, 'identificationModule': {'nctId': 'NCT05491759', 'briefTitle': 'A Study to Determine Optimal Absorption of Single Dose Omega-3', 'organization': {'class': 'INDUSTRY', 'fullName': 'RDC Clinical Pty Ltd'}, 'officialTitle': 'A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BTFISH-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Product 1 - AquaCelle Fish Oil Triglyceride', 'description': '1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle The dose will be consumed orally with 250 mL water.', 'interventionNames': ['Drug: Product 1 - AquaCelle Fish Oil Triglyceride']}, {'type': 'EXPERIMENTAL', 'label': 'Product 2 - AquaCelle Fish Oil Ethyl Ester', 'description': '1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle The dose will be consumed orally with 250 mL water.', 'interventionNames': ['Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester']}, {'type': 'EXPERIMENTAL', 'label': 'Product 3 - Standard Fish Oil Triglyceride', 'description': '1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).\n\nThe dose will be consumed orally with 250 mL water.', 'interventionNames': ['Drug: Product 3 - Standard Fish Oil Triglyceride']}], 'interventions': [{'name': 'Product 1 - AquaCelle Fish Oil Triglyceride', 'type': 'DRUG', 'description': '1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle.', 'armGroupLabels': ['Product 1 - AquaCelle Fish Oil Triglyceride']}, {'name': 'Product 2 - AquaCelle Fish Oil Ethyl Ester', 'type': 'DRUG', 'description': '1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle', 'armGroupLabels': ['Product 2 - AquaCelle Fish Oil Ethyl Ester']}, {'name': 'Product 3 - Standard Fish Oil Triglyceride', 'type': 'DRUG', 'description': '1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).', 'armGroupLabels': ['Product 3 - Standard Fish Oil Triglyceride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'RDC Global Pty Ltd', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'David Briskey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RDC Clinical Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}